Covidien recalls Newport HT70 Ventilator, REF: HT70M-JP-NA, HT70M-CN-NA, HT70M-ES-EU, HT70M-PT-BR, HT70M-SY-EU, HT70M-WW-EU, HT70M-WW-NA…

Recall date

May 21, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1915-2025

FDA classification

Class I

Brand / firm

Covidien

Sold / distributed

Worldwide - US Nationwide distribution including in the states of MA, CT, KS, OH, PR, NH, GA, WI, MS, VA, CO, TX, MN, AL, IA, NY, UT, NM, KY, RI, SD, PA, IA, CA, MO, HI, MI, IL, MT, NJ, TN, SC, FL, IN, AZ, ID, LA, WA, NC, MD, WY, NE, NV, ND, ME, AK, DE, OK, OR and the countries of Japan, Canada, Si…

Why it was recalled

Ventilator Printed Circuit Board Assembly may have two separate capacitors that may fail, which may result in the ventilator either shutting down during use, thus necessitating use of an alternate form of ventilation, or the shutdown alert alarm fails to alarm effectively during shut down, which may result in respiratory failure, hypoventilation, low oxygen saturation, hypoxia, treatment delay.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

Newport HT70 Ventilator, REF: HT70M-JP-NA, HT70M-CN-NA, HT70M-ES-EU, HT70M-PT-BR, HT70M-SY-EU, HT70M-WW-EU, HT70M-WW-NA, HT70-SY-EU. Newport HT70Plus Ventilator, REF: HT70PM-ES-EU, HT70PM-ES-NA, HT70PM-JP-NA, HT70PM-PT-BR, HT70PM-SY-AS, DLHT70PM-WW-NA, HT70PM-SY-NA, HT70PM-SY-UK, HT70PM-WW-EU, HT70PM-WW-UK, HT70PM-SY-EU, HT70PM-WWNA. HT70-2 CONTROL BOARD ROHS X1, REF: GR105796. HT70P CONTROL BOARD ROHS X1, REF: GR105795. HT70 Conversion Kit, REF: GRFSKHT70M-2.